Q4 2024 Upcoming FDA Decision Dates (PDUFAs)

Q4 2024 Upcoming FDA Decision Dates (PDUFAs)

As we head into a busy holiday season and look towards 2025, it’s important to stay up-to-date on the news in the ever-evolving biotech industry. During a year of transition such as 2024, the remaining FDA approval dates this year have the potential to solidify trends and shape the outlook for the industry in 2025.

Read on for an overview of the FDA’s upcoming decision dates for new drug approvals in the remainder of 2024.

 
DATE COMPANY NAME DRUG NAME USE/THERAPEUTIC AREA
10-04-2024 Biofrontera Ameluz Actinic keratosis (AK)
10-08-2024 Bristol Myers Squibb Neoadjuvant nivolumab (Opdivo) IIA to IIIB non–small cell lung cancer (NSCLC)
10-08-2024 Zealand Pharma Dasiglucagon Hypoglycemia in Congenital Hyperinsulinism
10-11-2024 Pfizer Hympavzi (marstacimab-hncq) Hemophilia A or B without inhibitors
10-15-2024 Intercept Pharmaceuticals Ocaliva (obeticholic acid) Primary biliary cholangitis (PBC)
10-17-2024 Avadel Pharmaceuticals Lumryz (sodium oxybate) Cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
10-21-2024 Camurus Oclaiz (CAM2029) Acromegaly
10-25-2024 Iterum Therapeutics ORLYNVAH™ (Oral Sulopenem) Uncomplicated Urinary Tract Infections
10-29-2024 Novartis Asciminib (Scemblix) Chronic myeloid leukemia
11-4-2024 Journey Medical Corporation DFD-29 (minocycline hydrochloride) Inflammatory lesions and erythema of rosacea
11-13-2024 PTC Therapeutics Upstaza (eladocagene exuparvovec) Aromatic L–amino Acid Decarboxylase (AADC) deficiency
11-16-2024 Autolus Therapeutics Obecabtagene autoleucel (obe-cel) Relapsed/refractory adult B-cell acute lymphoblastic leukemia (ALL)
11-27-2024 Roche Inavolisib HR+/HER2– PIK3CA+ Breast Cancer
11-28-2024 Applied Therapeutics Inc. Govorestat (AT-007) Galactosemia type 1
11-29-2024 Zymeworks & Jazz Pharmaceuticals Zanidatamab HER2-Positive Metastatic Biliary Tract Cancer
11-29-2024 BridgeBio Pharma Acoramidis Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
11-30-2024 Shorla Oncology SH-201 Leukemia and other cancers.
12-19-2024 Ionis Pharmaceuticals Olezarsen Familial chylomicronemia syndrome
12-20-2024 Lexicon Pharmaceutical Zynquista (sotagliflozin) Type 1 Diabetes and chronic kidney disease
12-26-2024 Rhythm Pharmaceuticals Imcivree (setmelanotide) Bardet-Biedl syndrome or POMC/LEPR deficiency
12-26-2024 Syndax Pharma Revumenib Relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemia
12-27-2024 Soleno Therapuetics DCCR (Diazoxide Choline) Prader-Willi Syndrome (PWS)
12-28-2024 Checkpoint Therapeutics Cosibelimab Advanced Cutaneous Squamous Cell Carcinoma
12-28-2024 Xcovery Holdings Ensartinib Anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC)
12-29-2024 Halozyme Therapeutics & Bristol Myers Squibb Opdivo (nivolumab) Advanced or Metastatic Solid Tumors
12-30-2024 Neurocrine Biosciences Crinecerfont Congenital adrenal hyperplasia (CAH)
Dec 2024 BeiGene Tevimbra (tislelizumab) Unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma
Q4 2024 AstraZeneca Tagrisso (osimertinib) Stage III EGFR-mutated lung cancer
Q3 2024 Upcoming FDA Decision Dates (PDUFAs)

Q3 2024 Upcoming FDA Decision Dates (PDUFAs)

As we move into the second half of 2024, following a hopeful uptick for the biotech industry in the first two quarters, it’s more important than ever to stay on top of the news in this ever-evolving industry. Some of the most crucial developments to keep up with are the approaching FDA approval dates, which provide insight into the industry’s outlook for the rest of the year.

Read on for a rundown of the FDA’s upcoming decision dates for new drug approvals in the third quarter of 2024.

 
DATE COMPANY NAME DRUG NAME USE/THERAPEUTIC AREA
01/3/2024 Checkpoint Therapeutics Cosibelimab Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
01/5/2024 Novan Berdazimer Gel, 10.3% Molluscum Contagiosum
01/12/2024 Astellas Olbetuximab Gastroesophageal junction (GEJ) adenocarcinoma
01/12/2024 Astellas Pharma Zolbetuximab Gastric Cancer
01/13/2024 GC Biopharma GC5107B Primary Humoral Immunodeficiency (PI)
01/17/2024 Merck WELIREG (belzutifan) Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC)
01/20/2024 Merck Keytruda (pembrolizumab) Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
01/20/2024 Theratechnologies Tesamorelin F8 Formulation Reduction of excess abdominal fat in adults with HIV who have lipodystrophy
01/23/2024 Heron Therapeutics ZYNRELEF (bupivacaine and meloxicam) Post-Operative Pain
01/24/2024 Liquidia Corporation Yutrepia (treprostinil) Pulmonary Arterial Hypertension (PAH); Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD)
01/26/2024 Defender Pharmaceuticals scopolamine (DPI-386) Motion Sickness
01/31/2024 Sanofi and Regeneron Dupixent (dupilumab) Eosinophilic esophagitis (EoE)
01/31/2024 Vyluma NVK002 Myopia
02/13/2024 Ipsen Onivyde (irinotecan liposome injection) Metastatic pancreatic ductal adenocarcinoma
02/22/2024 Venatorx Pharmaceuticals cefepime-taniborbactam Complicated Urinary Tract Infections (cUTI), including Pyelonephritis
02/24/2024 Iovance Biotherapeutics Lifileucel Advanced Melanoma
02/24/2024 Alvotech AVT02 Inflammatory diseases including rheumatoid arthritis
02/26/2024 Minerva Neurosciences Roluperidone Schizophrenia- Negative Symptoms
03/4/2024 Eyenovia APP13007 Post-operative inflammation and pain following ocular surgery
03/4/2024 Vanda Pharmaceuticals HETLIOZ (tasimelteon) Non-24-Hour Sleep-Wake Disorder (Non-24) in adults
03/8/2024 Viatris and Mapi Pharma Copaxone (Glatiramer Acetate Depot) Relapsed forms of multiple sclerosis (MS)
03/13/2024 Mirum Pharmaceuticals Livmarli (maralixibat) Cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC)
03/14/2024 Madrigal Pharmaceuticals Resmetirom Nonalcoholic steatohepatitis (NASH)
03/14/2024 Bristol Myers Squibb Breyanzi (lisocabtagene maraleucel) Relapsed/refractory large B-cell lymphoma (LBCL)
03/16/2024 Optinose XHANCE Chronic rhinosinusitis with nasal polyps (CRSwNP)
03/18/2024 Orchard Therapeutics OTL-200 Metachromatic leukodystrophy (MLD)
03/21/2024 Italfarmaco Group Givinostat Duchenne Muscular Dystrophy (DMD)
03/23/2024 Incyte ruxolitinib myelofibrosis, polycythemia vera, and graft vs. host disease (GVHD)
03/26/2024 Merck Sotatercept Pulmonary arterial hypertension (PAH)
03/27/2024 Akebia Therapeutics Vadadustat Anemia in patients with CKD undergoing dialysis
03/27/2024 Esperion NEXLETOL (bempedoic acid) Lowers the level of cholesterol in the blood
03/30/2024 Vertex and CRISPR Therapeutics Casgevy (exagamglogene autotemcel) Severe Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia
03/31/2024 Rocket Pharmaceuticals RP-L201 (marnetegragene autotemcel) Leukocyte adhesion deficiency-I (LAD-I)
03/31/2024 Regeneron Pharmaceuticals Odronextamab (REGN1979) Relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma (DLBCL)
04/01/2024 AstraZeneca Voydeya (danicopan) Extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria (PNH)
04/02/2024 Vanda Pharmaceuticals Fanapt Manic or mixed episodes associated with bipolar I disorder in adults
04/03/2024 Basilea Pharmaceutica AG ZEVTERA (Ceftobiprole) SAB infections and ABSSSI in adults and for CABP in adults and pediatric patients
04/04/2024 Bristol Myers Squibb & 2seventy Bio Abecma (idecabtagene vicleucel; ide-cel) Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy
04/05/2024 Janssen & Legend Biotech Carvykti (ciltacabtagene autoleucel; cilta-cel) Relapsed or refractory multiple myeloma
04/05/2024 Bristol Myers Squibb Opdivo (nivolumab) Unresectable or metastatic urothelial carcinoma
04/05/2024 Supernus Pharmaceuticals SPN-830 Motor fluctuations (OFF episodes) in Parkinson’s disease
04/05/2024 AbbVie/Immunogen ELAHERE Platinum-Resistant Ovarian Cancer
04/23/2024 ImmunityBio N-803 BCG-unresponsive non-muscle invasive bladder carcinoma (NMIBC)
04/28/2024 Aquestive Therapeutics Libervant (diazepam) Buccal Film Seizure clusters in patients between two and five years of age
04/29/2024 PharmaTher KETARX (Ketamine) Mental health, neurological and pain disorders
04/30/2024 Day One Biopharmaceuticals Tovorafenib Relapsed or progressive pediatric low-grade glioma (pLGG)
04/30/2024 X4 Pharmaceuticals Mavorixafor WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome
04/30/2024 Neurocrine Biosciences Inc INGREZZA (valbenazine) Tardive dyskinesia and chorea associated with Huntington’s disease
05/09/2024 Astellas Pharma Inc. PADCEV (enfortumab vedotin-ejfv) Advanced Bladder Cancer
05/09/2024 Merck KEYTRUDA (pembrolizumab) Plus Padcev (enfortumab vedotin-ejfv) Locally advanced or metastatic urothelia
05/09/2024 Pfizer & GENMAB Tivdak Recurrent or Metastatic Cervical Cancer
05/13/2024 Dynavax Technologies Corp HEPLISAV-B Infection caused by all known subtypes of hepatitis B virus
05/14/2024 Ascendis Pharma TransCon PTH (Palopegteriparatide) Hypoparathyroidism
05/23/2024 Bristol Myers Squibb Breyanzi (lisocabtagene maraleucel) Relapsed or refractory follicular lymphoma (FL)
05/25/2024 Abeona Therapeutics Pz-cel Recessive dystrophic epidermolysis bullosa
05/30/2024 Daiichi Sankyo & AstraZeneca Enhertu (trastuzumab deruxtecan) Unresectable or Metastatic HER2 Positive Solid Tumors
05/31/2024 Bristol Myers Squibb Breyanzi (lisocabtagene maraleucel) Relapsed or refractory mantle cell lymphoma (MCL)
06/04/2024 Catalyst Pharmaceutical Firdapse (amifampridine) Lambert-Eaton myasthenic syndrome (“LEMS”)
06/07/2024 GSK AREXVY (RSV Vaccine) Prevention of RSV disease in adults aged 50-59 at increased risk
06/10/2024 Ipsen and GENFIT Elafibranor Rare cholestatic liver disease, primary biliary cholangitis (PBC)
06/12/2024 Amgen Tarlatamab Advanced small cell lung cancer (SCLC)
06/15/2024 Bristol-Myers Squibb Augtyro (repotrectinib) NTRK-Positive Locally Advanced or Metastatic Solid Tumors
06/16/2024 Geron Corporation Imetelstat Lower risk myelodysplastic syndromes (MDS)
06/17/2024 Merck & Ligand Pharmaceuticals V116 Prevent of invasive pneumococcal disease and pneumococcal pneumonia
06/21/2024 Sarepta Therapeutics ELEVIDYS (delandistrogene moxeparvovec-rokl) Duchenne muscular dystrophy (DMD)
06/21/2024 Argenx VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Chronic inflammatory demyelinating polyneuropathy (CIDP)
06/21/2024 Merck & Co Inc. KEYTRUDA (pembrolizumab) Advanced endometrial cancer
06/21/2024 Bristol-Myers Squibb KRAZATI (adagrasib) KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)
06/21/2024 Harmony Biosciences WAKIX (pitolisant) Excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy
06/26/2024 Merck & Daiichi Sankyo Patritumab deruxtecan (HER3-DXd) Locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies
06/26/2024 Verona Pharma plc Ensifentrine Asthma and chronic obstructive pulmonary disease (COPD)
06/27/2024 Sanofi Dupixent (dupilumab) Chronic obstructive pulmonary disease (COPD) with type 2 inflammation
06/28/2024 AbbVie & GENMAB EPKINLY (Epcoritamab-bysp) Elapsed or Refractory Follicular Lymphoma (FL)
06/30/2024 Rocket Pharmaceuticals RP-L201 (marnetegragene autotemcel) Leukocyte adhesion deficiency-I (LAD-I)
07/7/2024 Arcutis Biotherapeutics Inc. Roflumilast Cream 0.15% Atopic Dermatitis in Adults and Children Down to Age 6
07/15/2024 Orexo AB OX124 opioid overdose
07/19/2024 Phathom Pharmaceuticals Inc VOQUEZNA (vonoprazan) Tablets Heartburn associated with Non-Erosive GERD
07/25/2024 AstraZeneca IMFINZI Resectable non-small cell lung cancer
07/27/2024 Alpha Cognition Inc. ALPHA-1062 Mild-to-moderate Alzheimer’s disease in U.S.
07/31/2024 Xspray Pharma Dasynoc (dasatinib amorphous) Chronic myeloid leukemia (CML)
08/4/2024 Adaptimmune Therapeutics Afami-cel Advanced synovial sarcoma
08/10/2024 Humacyte, Inc. Human Acellular Vessel Vascular trauma
08/13/2024 Citius Pharmaceuticals LYMPHIR (denileukin diftitox) Relapsed or refractory cutaneous T-cell lymphoma (CTCL)
08/14/2024 Ascendis Pharma TransCon PTH (palopegteriparatide) Hypoparathyroidism
08/14/2024 Gilead Sciences Seladelpar Primary Biliary Cholangitis (PBC)
08/20/2024 Royal Pharma vorasidenib IDH-mutant glioma
08/22/2024 Regeneron Pharmaceuticals Linvoseltamab Relapsed/refractory (R/R) multiple myeloma (MM)
08/23/2024 GSK Jemperli (dostarlimab) Primary advanced or recurrent endometrial cancer
08/28/2024 Incyte Corporation / Syndax Pharmaceuticals Axatilimab Chronic Graft-Versus-Host Disease
09/5/2024 Travere Therapeutics / Ligand Pharmaceuticals Filspari (sparsentan) IgA Nephropathy
09/7/2024 AVADEL PHARMACEUTICALS LUMRYZ Cataplexy or EDS in the pediatric narcolepsy population
09/18/2024 VANDA PHARMACEUTICALS Tradipitant Gastroparesis
09/21/2024 Zevra Therapeutics / XOMA Corporation Arimoclomol Niemann-Pick disease type C
09/23/2024 Heron Therapeutics ZYNRELEF Instillation to produce postsurgical analgesia for up to 72 hours after soft tissue and orthopedic procedures
09/24/2024 IntraBio IB1001 (N-acetyl-L-leucine) Niemann-Pick disease Type C (NPC)
09/25/2024 Merck KEYTRUDA (pembrolizumab) Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma
09/26/2024 Syndax Pharmaceuticals Revumenib Relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemia
09/26/2024 Bristol-Myers Squibb KarXT Schizophrenia in adults
09/27/2024 Regeneron Pharmaceuticals / Sanofi Dupixent Chronic obstructive pulmonary disease (COPD) with type 2 inflammation
09/27/2024 Sanofi Sarclisa (isatuximab-irfc) in combination with bortezomib, lenalidomide, and dexamethasone treatment of transplant-ineligible newly diagnosed multiple myeloma
Q2 2024 Pfizer Fidanacogene elaparvovec Hemophilia B
Q2 2024 BeiGene Beukina (zanubrutinib) Relapsed or refractory follicular lymphoma
Q2 2024 Roche XOLAIR (omalizumab) Asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU)
Q2 2024 AstraZeneca TAGRISSO (osimertinib) Non-small cell lung cancer (NSCLC)
Q2 2024 AstraZeneca FluMist Quadrivalent Active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
Q2 2024 Upcoming FDA Decision Dates (PDUFAs)

Q2 2024 Upcoming FDA Decision Dates (PDUFAs)

When you work in an industry as rapidly changing as biotechnology, it’s crucial to stay up to date. Awareness of the FDA’s new drug approval dates is especially crucial: the decisions put forth on these dates can significantly affect the outlook of the companies involved, and these ramifications often reverberate through the industry as a whole.

Read on for a rundown of the FDA’s upcoming decision dates for new drug approvals in the first quarter of 2024.

DATE COMPANY NAME DRUG NAME USE/THERAPEUTIC AREA
04/01/2024 AstraZeneca Voydeya (danicopan) Extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria (PNH)
04/02/2024 Vanda Pharmaceuticals Fanapt Manic or mixed episodes associated with bipolar I disorder in adults
04/03/2024 Basilea Pharmaceutica AG ZEVTERA (Ceftobiprole) SAB infections and ABSSSI in adults and for CABP in adults and pediatric patients
04/04/2024 Bristol Myers Squibb & 2seventy Bio Abecma (idecabtagene vicleucel; ide-cel) Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy
04/05/2024 Janssen & Legend Biotech Carvykti (ciltacabtagene autoleucel; cilta-cel) Relapsed or refractory multiple myeloma
04/05/2024 Bristol Myers Squibb Opdivo (nivolumab) Unresectable or metastatic urothelial carcinoma
04/05/2024 Supernus Pharmaceuticals SPN-830 Motor fluctuations (OFF episodes) in Parkinson’s disease
04/05/2024 AbbVie/Immunogen ELAHERE Platinum-Resistant Ovarian Cancer
04/23/2024 ImmunityBio N-803 BCG-unresponsive non-muscle invasive bladder carcinoma (NMIBC)
04/28/2024 Aquestive Therapeutics Libervant (diazepam) Buccal Film Seizure clusters in patients between two and five years of age
04/29/2024 PharmaTher KETARX (Ketamine) Mental health, neurological and pain disorders
04/30/2024 Day One Biopharmaceuticals Tovorafenib Relapsed or progressive pediatric low-grade glioma (pLGG)
04/30/2024 X4 Pharmaceuticals Mavorixafor WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome
04/30/2024 Neurocrine Biosciences Inc INGREZZA (valbenazine) Tardive dyskinesia and chorea associated with Huntington’s disease
05/09/2024 Astellas Pharma Inc. PADCEV (enfortumab vedotin-ejfv) Advanced Bladder Cancer
05/09/2024 Merck KEYTRUDA (pembrolizumab) Plus Padcev (enfortumab vedotin-ejfv) Locally advanced or metastatic urothelia
05/09/2024 Pfizer & GENMAB Tivdak Recurrent or Metastatic Cervical Cancer
05/13/2024 Dynavax Technologies Corp HEPLISAV-B Infection caused by all known subtypes of hepatitis B virus
05/14/2024 Ascendis Pharma TransCon PTH (Palopegteriparatide) Hypoparathyroidism
05/23/2024 Bristol Myers Squibb Breyanzi (lisocabtagene maraleucel) Relapsed or refractory follicular lymphoma (FL)
05/25/2024 Abeona Therapeutics Pz-cel Recessive dystrophic epidermolysis bullosa
05/30/2024 Daiichi Sankyo & AstraZeneca Enhertu (trastuzumab deruxtecan) Unresectable or Metastatic HER2 Positive Solid Tumors
05/31/2024 Bristol Myers Squibb Breyanzi (lisocabtagene maraleucel) Relapsed or refractory mantle cell lymphoma (MCL)
06/04/2024 Catalyst Pharmaceutical Firdapse (amifampridine) Lambert-Eaton myasthenic syndrome (“LEMS”)
06/07/2024 GSK AREXVY (RSV Vaccine) Prevention of RSV disease in adults aged 50-59 at increased risk
06/10/2024 Ipsen and GENFIT Elafibranor Rare cholestatic liver disease, primary biliary cholangitis (PBC)
06/12/2024 Amgen Tarlatamab Advanced small cell lung cancer (SCLC)
06/15/2024 Bristol-Myers Squibb Augtyro (repotrectinib) NTRK-Positive Locally Advanced or Metastatic Solid Tumors
06/16/2024 Geron Corporation Imetelstat Lower risk myelodysplastic syndromes (MDS)
06/17/2024 Merck & Ligand Pharmaceuticals V116 Prevent of invasive pneumococcal disease and pneumococcal pneumonia
06/21/2024 Sarepta Therapeutics ELEVIDYS (delandistrogene moxeparvovec-rokl) Duchenne muscular dystrophy (DMD)
06/21/2024 Argenx VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Chronic inflammatory demyelinating polyneuropathy (CIDP)
06/21/2024 Merck & Co Inc. KEYTRUDA (pembrolizumab) Advanced endometrial cancer
06/21/2024 Bristol-Myers Squibb KRAZATI (adagrasib) KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)
06/21/2024 Harmony Biosciences WAKIX (pitolisant) Excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy
06/26/2024 Merck & Daiichi Sankyo Patritumab deruxtecan (HER3-DXd) Locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies
06/26/2024 Verona Pharma plc Ensifentrine Asthma and chronic obstructive pulmonary disease (COPD)
06/27/2024 Sanofi Dupixent (dupilumab) Chronic obstructive pulmonary disease (COPD) with type 2 inflammation
06/28/2024 AbbVie & GENMAB EPKINLY (Epcoritamab-bysp) Elapsed or Refractory Follicular Lymphoma (FL)
06/30/2024 Rocket Pharmaceuticals RP-L201 (marnetegragene autotemcel) Leukocyte adhesion deficiency-I (LAD-I)
Q2 2024 Pfizer Fidanacogene elaparvovec Hemophilia B
How to Build Your Professional Network

How to Build Your Professional Network

Author:  Tara Smylie

About one thing, modern psychology is certain: we humans are social creatures. Whether you’re looking to skill up, or take on new projects as a freelancer – don’t underestimate the power of connections!

Below you’ll find some useful tips to help you build a thriving network of connections in your professional life.

1. Social Media Is Your Friend

Intentional outreach on Linkedin is a fabulous place to start. Don’t be scared to pull the trigger and connect with someone you don’t know – especially if you add a short, sweet, and to-the-point note to go along with it.

Joining intentional groups on Linkedin is another great way to meet people in your field. Let’s say you’re a chemical engineer looking to learn more about the management aspect of the life science field. By joining a group of like-minded individuals, you’ll be exposed to a wide variety of perspectives, resources, and ideas that you may never have even thought of.

2. Expand your reach – geographically and topically

You never know who you’re going to cross paths with, and how you might help each other when you do. Though it’s important to know people with similar goals, another key part of building a solid network is finding people different from yourself to connect with. If you’re all bringing the same thing to the table, there’s a limit to how much you can partner with each other and learn from each other.

3. Get out to in-person events

They’re not obsolete yet! There’s nothing quite like in-person connection to get the ball rolling with someone new – and your wheels spinning with new ideas for collaboration. In-person events allow you to gain a sense of someone’s personality more quickly, and to ask questions that you might not feel comfortable asking in an online setting. Often there are activities, workshops, or other focal points of in-person networking events too – so you’ll likely have a career-relevant icebreaker to get the blood flowing.

4. Reach out for assistance

People love being asked for help. It makes them feel important, and builds their confidence in their own skills and reputation. If you’re seeking opportunities to learn something new, are trying to start a new group, or simply desire someone to talk to about your latest career undertakings, don’t hesitate to reach out to someone. Asking for help is a vulnerable thing to do, and will only deepen the connections you have.

And as long as you’re not being pushy about it, don’t worry about being a burden. Before you know it, the shoe will be on the other foot, and it will be the helpers who came through for you that need your assistance.

5. Enroll in a course

What better way to meet others in your chosen field than to learn the same new skills together, at the same time?

Nowadays, it’s trickier than ever to meet people in a school setting – so many offerings are online-only. Of course, it’s possible to connect with classmates online if you’re determined enough – but consider in-person courses first if you’re looking to fast-track the expansion of your network.

In an educational environment, everyone is looking to improve themselves somehow, and to add something new to their lives. This openness to change makes people especially open to new connections, too – so grab the chance to take in-person courses and classes whenever you can.

The Takeaway

If there’s one thing we know about connections, it’s that they lead to more connections. Stay home and think about how great it would be to have a network, and you’ll probably find yourself expanding your circle at a snail’s pace. But choose to leap out of your nest and into the world – even if you have to flail and fumble a little bit – and you’ll come away happier, more fulfilled, and ready to soar into the next phase of your career.

Here at Sci.bio, we work with a variety of candidates from new graduates to experienced executives, and have myriad open roles. We pride ourselves on connecting our highly discerning clients with candidates who fit their specific needs. Check out our job search page to see current openings and follow us on LinkedIn for more information.

Related Blogs:

  1. Why Online Networking Can Make a Difference in a Job Search
  2. How to Build Relationships with Recruiters
  3. Useful Online Courses to Beef Up your Resume
Upcoming FDA Decision Dates (PDUFAs)

Upcoming FDA Decision Dates (PDUFAs)

When you work in an industry as rapidly changing as biotechnology, it’s crucial to stay up to date. Awareness of the FDA’s new drug approval dates is especially crucial: the decisions put forth on these dates can significantly affect the outlook of the companies involved, and these ramifications often reverberate through the industry as a whole.

Read on for a rundown of the FDA’s upcoming decision dates for new drug approvals in the first quarter of 2024.

DATE COMPANY NAME DRUG NAME USE/THERAPEUTIC AREA
01/20/2024 Merck Keytruda (pembrolizumab) Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
01/22/2024 Theratechnologies Tesamorelin F8 Formulation Reduction of excess abdominal fat in adults with HIV who have lipodystrophy
01/23/2024 Heron Therapeutics ZYNRELEF (bupivacaine and meloxicam) Post-Operative Pain
01/24/2024 Liquidia Corporation Yutrepia (treprostinil) Pulmonary Arterial Hypertension (PAH); Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD)
1/26/2024 Defender Pharmaceuticals scopolamine (DPI-386) Motion Sickness
1/31/2024 Sanofi and Regeneron Dupixent (dupilumab) Eosinophilic esophagitis (EoE)
1/31/2024 Vyluma NVK002 Myopia
2/13/2024 Ipsen Onivyde (irinotecan liposome injection) Metastatic pancreatic ductal adenocarcinoma
2/22/2024 Venatorx Pharmaceuticals cefepime-taniborbactam Complicated Urinary Tract Infections (cUTI), including Pyelonephritis
02/24/2024 Iovance Biotherapeutics Lifileucel Advanced Melanoma
02/24/2024 Alvotech AVT02 Inflammatory diseases including rheumatoid arthritis
02/26/2024 Minerva Neurosciences Roluperidone Schizophrenia- Negative Symptoms
3/4/2024 Eyenovia APP13007 Post-operative inflammation and pain following ocular surgery
3/4/2024 Vanda Pharmaceuticals HETLIOZ (tasimelteon) Non-24-Hour Sleep-Wake Disorder (Non-24) in adults
03/08/2024 Viatris and Mapi Pharma Copaxone (Glatiramer Acetate Depot) Relapsed forms of multiple sclerosis (MS)
3/13/2024 Mirum Pharmaceuticals Livmarli (maralixibat) Cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC)
3/14/2024 Madrigal Pharmaceuticals Resmetirom Nonalcoholic steatohepatitis (NASH)
3/14/2024 Bristol Myers Squibb Breyanzi (lisocabtagene maraleucel) Relapsed/refractory large B-cell lymphoma (LBCL)
3/16/2024 Optinose XHANCE Chronic rhinosinusitis with nasal polyps (CRSwNP)
3/18/2024 Orchard Therapeutics OTL-200 Metachromatic leukodystrophy (MLD)
3/21/2024 Italfarmaco Group Givinostat Duchenne Muscular Dystrophy (DMD)
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3/31/2024 Rocket Pharmaceuticals RP-L201 (marnetegragene autotemcel) Leukocyte adhesion deficiency-I (LAD-I)
3/31/2024 Regeneron Pharmaceuticals Odronextamab (REGN1979) Relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma (DLBCL)
Best Practices in Recruiting

Best Practices in Recruiting

Authors: Gabrielle Bauer & Tara Smylie

Big-picture ideas to help recruiters—and those who use them—play their A game

INTRODUCTION to BEST PRACTICES IN RECRUITING

In an era of rapid growth for biotech and life science companies, STEM-savvy talent experts play an especially important role in the ecosystem. Becoming a life science recruiter takes knowledge of the industry, a wide social network, and business acumen. Working with one takes a keen sense of what you’re looking for, and the ability to put it into words.

Whether you’re considering becoming a recruiter, in the midst of a recruiting career, or interested in using recruiting services, this survey article will give you the insights and confidence to do it right.

BECOMING A RECRUITER

Before you walk the recruiter’s walk, you need to know who you are and where you’re heading.

Recruiting: who knew? Most life science grads don’t immediately think of recruiting as a career option – but they should. Variety, flexibility, and mobility into a variety of other career paths are just some of the perks it offers. And let’s not forget about the money: if working on commission, recruiters can enjoy an uncapped earning potential.

Working as a recruiter, you’ll also get the chance to draw on your own previous work experience. As an example, perhaps you’ve spent your most recent working years in a lab, dealing with regulations and assisting with complex processes. In such a case, you can start out by billing yourself as a recruiter specializing in lab operations, and build out your services from there.

Another reason to consider recruiting: getting a head start on future career ideas for yourself. This holds especially true if you’re still looking to map out a long-term career trajectory, but it can apply to anyone. There’s nothing like being a matchmaker to show you what makes a great partnership – workplace or otherwise. As you learn the qualities most important for different roles, you’ll naturally gain insights about the positions that would suit you best.

But skills are just one piece of the pie: personality also comes into play. According to a survey of nearly 9,000 talent experts, recruiters tend to be enterprising, outgoing, and have a strong sense of social responsibility. The through-line: they fundamentally enjoy being with people. If you’re a natural networker and enjoy leveraging your contacts to help out friends in need, recruiting ticks all the important boxes. This doesn’t mean the profession is off-limits to quieter types, though. If recruiting appeals to you, start exploring the possibilities.

What to expect

As of April 2022, the life sciences had the second-lowest unemployment rate of all U.S. industries. It’s a job-seeker’s market, with companies often scrambling to find talent they urgently need. Business is booming for recruiters, too: 86% of life science talent acquisition professionals say they expect their teams to either grow or remain stable in 2023.

In many ways, the life sciences are a dream come true for recruiters. The industry features a higher-than-average percentage of highly skilled positions, and turnover is high. Career possibilities in the field continue to diversify, with burgeoning niches in personalized medicine, data analytics, and digital health, among others. As a life science recruiter, you’ll participate in the excitement of matching these novel skills with organizations who desperately need them.

Top trends in talent acquisition and recruiting

If you want to attract candidates who are up-to-date and in-the-know, you’ll have to get on their level. As of 2023, top trends in recruiting include:

  • Remote interviewing: This facilitates collaborative hiring.
  • Emphasis on candidate experience: Companies that prioritize employee well-being are more successful than those that don’t.
  • Diversity, equity and inclusion: Statistics show that a culturally rich workplace is good for business.
  • Contingent workers. Businesses and workers alike have realized how profitable contract work can be.

Niching and branding

As a new recruiter, you may feel torn. Do you take on as many projects as possible, or niche up early to establish a specialized reputation and client base? The short answer: a bit of both. While you don’t need to specialize too quickly or narrowly, it’s worth honing in on some areas of specialty as you develop your business.

Let’s say you’ve established some connections with microbiologists and feel confident you can quickly place top-quality talent in the field. If you promote yourself accordingly, your clients and network associates will pick up on your specialized knowledge and experience in this area. Should they ever need a microbiologist, they’ll remember your name.

Examples of recruitment specialties in the life sciences include gene therapy, immuno-oncology, clinical development, medical devices, medical writing, and many more. To narrow it down, ask yourself the following:

  • What kinds of positions do you find most interesting?
  • Does your previous recruiting experience point you in an obvious direction?
  • Do you have especially large networks in certain areas?

Use your answers to guide your decision process. Next step: spread the word. To create a compelling personal brand, keep a few fundamental W’s in mind: who do you recruit for, and what do you offer them? Why does recruiting mean so much to you? Answer these questions honestly and specifically, and you’ll attract a customer base that wants to buy what you’re selling.

As far as possible, keep your brand visuals consistent across all marketing tools, from your website to your business cards. Decide as soon as possible which font types, color scheme, design style, and logo you’re going to use for all your content. That’s not to say you can never change your style – just remember that consistency builds brand recognition and “brand memory,” leading clients and candidates to think of you first.

RECRUITING IQ

Like most professions, effective recruiting is more about working smart than about putting in long hours and hoping something sticks. A skilled recruiter understands the value of a network, and the synergy between professionalism and personal connections.

Nuts and bolts

Keep your expectations realistic. A biotech start-up, no matter how promising, won’t have the same gravitational pull that a large pharma company does. That said, the way you present a company to candidates carries a lot of power. Don’t misrepresent the organization, but feel free to talk about organizational goals, backstory, or employee mobility to pique their interest.

Second in your toolbox: face-to-face networking events. Where possible, add all new connections on LinkedIn and exchange social media identifiers. And as you forge new connections, remember: just because you don’t need a candidate now doesn’t mean they won’t be a great match for a future project. Relationship-building forms the core of recruiting, so you’ll want to cast a wide net to maximize your success.

To maximize social media engagement, make sure your social content is – you guessed it – engaging. Think images, graphics, and open-ended questions that stimulate discussion. On LinkedIn, posts that include photo content receive 98 percent more comments than those that feature text only. Keep this in mind as you build an online presence.

Another digital trend: today’s social media users are looking to see the “human” side of a brand or organization. As you optimize your social media for recruitment, don’t only post about projects and accomplishments. Mix things up a bit by posting about networking events, what led you to this career choice, and/or the difference you hope to make in the world as a recruiter.

Assessing your social media strategy

Every strategy must have an evaluation component, and social media is no exception. Here’s how to make sure you’re packing a punch with your digital outreach.

  • Set goals and priorities: Create a ranked list of your social media goals.
  • Audit your audience: Find out the type of content your audience likes best – or just ask them – and give them more of the same.
  • Monitor the competition: Find out how the successful competition is engaging their audience and consider pulling a few tricks from their book.
  • Set up a monitoring program: The popular Google Analytics reporting system, for example, can help you segment and identify the sources of your social traffic.

Keep it personal

Treat your candidates like people so they don’t fall through the cracks. When they don’t get the job, let them know why. This makes for a better end-to-end experience for them – and as a result, increases the likelihood that they’ll take your feedback, skill up, and come back even better prepared when the next opportunity arises.

To forge and maintain a connection with your candidate pool, advertise all new openings on social media, making sure your job postings are readable on mobile, and invite people to send you referrals. And don’t discount previous candidates who impressed you, but weren’t quite right at the time. Reconnecting with previous applicants can save you time, dollars, and a whole lot of stress. When you reach out, make sure to remind these former candidates who you are, how you know them, and what impressed you about their application the first time around.

Skill up during down times

When the hiring market is down, take the opportunity to hone your skills, strategize, and connect (or reconnect). The circumstances may have you feeling uncertain or anxious, but consider the bright side: less time spent on the daily grind means more time to work on your long-term goals. During a slower season, you can still reach out to employers and candidates and start building relationships for when you really need them.

A slower season also affords you the time to review your process. In particular, hone in on four key metrics: time to hire, cost per hire, usual sources of hire, and employment acceptance rates. Are these stats stacking up as you’d like them to? Maybe you could cut out a few formalities to streamline your process, or maybe you’re still subscribed to web recruitment services you no longer need. What feels like an endless lull in work will soon become a distant memory –and your current efforts will pay off when business picks up again.

WORKING WITH A RECRUITER

If you’re a life sciences company thinking of working with a recruiter, start with a basic assessment: why do it, which recruiter to work with, and how to work together.

Why use a recruiter in the first place

Specialized roles require a specialized search process. If you’re looking for an entry-level data analyst, you may be able to conduct the search on your own. But if you’re looking for, say, an experienced immunology consultant, a recruiter becomes a strategic asset. Sure, it costs more than doing it yourself – but considering the talent you find could stick around for years, the ROI will likely work in your favor.

Recruiters can also help you zero in on “cross-functional” candidates—people who bring unusual combinations of skills to the table. You’re more likely to find that microbiologist with management skills through a recruiter than on your own. And don’t underestimate the value of referrals from existing employees – especially when working with recruiters. A full 88 percent of businesses view referrals as their best hires, so it’s worth considering the value of this hiring pipeline. To maximize efficiency and avoid misunderstandings, you and your recruiter should establish a process for them to obtain employee referrals and follow up on the best ones.

Choose with care

If it sounds too good to be true, it probably is. When selecting a talent scout, the biggest red flag is dishonesty. If a recruiter displays “toxic positivity,” makes claims that sound unrealistic, or has an overly pushy sales pitch, they’re most likely trying to cover up a gap in their abilities.

Along with honesty and professionalism, experience in STEM fields should top your list of criteria. This doesn’t have to be a degree or a long-term job – courses, workshops, and previous recruitment experience in the industry can all give you a sense of their scientific background. If their LinkedIn profile doesn’t offer proof either way, but you still have a good feeling about working with them, reach out to them with questions to fill in the blanks.

To suss out a recruiter’s aptitude for your particular project, get very specific with your questions. If you’re considering someone who offers special expertise in science/biotech, be sure to ask how they tailor their services to the industry. This goes especially for niche, highly skilled positions: before you sign any contracts, they’ll need to prove they have a tried-and-true method of sourcing the best.

Top-five questions to ask candidate recruiters

  1. What is your search process, including for difficult-to-fill positions?
  2. Have you placed candidates in X or Y roles before?
  3. How do you handle clients with changing hiring needs?
  4. How do you manage referrals from internal employees?
  5. What is your approach to difficult-to-fill positions?

A model for all seasons

Selecting the right recruitment model is an art unto itself. If you’re hiring consistently and have the budget for it, an in-house recruiter may make the most sense. At the other end of the spectrum, a contingency recruiter can “pinch hit” for you if a hard-to-fill position calls for recruitment expertise beyond your usual requirements. As a further alternative, you can build a long-term partnership with the same external recruiter. With each new hire, they will gain a better and better sense of how your company works and how to best meet your talent needs.

When you need help finding a short-term candidate, consider the “temporary” and “temp-to-hire” recruitment models, which fulfill distinct strategic objectives. Temporary recruitment focuses on meeting short-term business demands. The temp-to-hire (a.k.a. temp-to-permanent) approach also seeks to meet a current need, but with the expectation that the temporary position will segue into a permanent one. Compared to the standard approach of giving new hires a probationary period, temp-to-hire saves costs and incurs less liability.

Whichever recruiting model you choose, a recruiter with an intelligent sourcing process puts you a step ahead. An essential precursor to recruiting, sourcing ensures that candidates meet a minimum qualification standard before being considered for a position. Find a recruiter you trust with sourcing, and you can rest easy knowing that every candidate you interview has met a suitable bar of skills and ambition.

Recruiter vs. headhunter: What’s the difference?

Headhunters find a “head” to fill a specific job, while recruiters work to fill many different job openings. Headhunters are typically called in to fill senior positions that require a unique blend of experience and skills. Recruiters often have an industry specialty and tend to establish longer-term relationships with both clients and candidates.

A LEG UP ON THE COMPETITION

The right recruiter will help you attract and retain the best, while saving time and resources.

Diving into the talent pool

In a competitive hiring market, a recruiter can help you hire quickly and efficiently. With demand for candidates outstripping supply, your usual hiring strategies may fall short. That’s where recruiters come in: between their existing network, referrals, and specialized outreach services, they can connect with candidates you would never know about on your own.

This includes people who need to wear more than one hat. The smartest talent experts understand that scientific skills come in many shades, and each role will call for a slightly different mix. Sure, one of your candidates might be an expert at clinical trial regulations – but that doesn’t mean they’re going to excel at long-term product strategy planning. With the help of a talent-optimization expert, you can ensure you’re not wasting all your efforts on square pegs.

The dreaded slowdown

If you experience a lag in company growth, financial concerns may cause you to hesitate to use recruiting services. While an understandable concern, working a recruiter into your budget could help revive your business. And when job candidates are scarce, you and the recruiter can work together to identify promising late-stage interviewees from previous hiring processes as well as passive candidates who may be interested in switching teams.

Hiring slowdowns often happen in the summer — incidentally, the time when thousands of college students become job-hungry graduates. Though these candidates may require a little extra TLC to train, they can easily make up for their lack of experience in energy and attitude. Working with a recruiter can help you identify the most reliable and ambitious of the bunch.

Hiring vision

Who do you want to hire and how do you plan to keep them? These are the fundamental questions behind “talent acquisition” and “talent management.”

Talent acquisition refers to the process of finding and attracting top-quality candidates, which involves relationship building, branding, and business smarts. Talent management, meanwhile, has to do with retaining and satisfying employees once they’re already on board. Think transparent company structure, workplace flexibility, and a compelling benefits package.

Of course, the two processes aren’t entirely separate. Well-managed talent will boost your organizational reputation, leading to smoother talent acquisition. By the same token, a well-thought-out hiring process will help your company attract candidates that suit their roles and will thus deliver more satisfied and productive employees.

An intelligent talent screening system – the bread and butter of recruiting – paves the way for a smooth acquisition process. This system could involve phone interviews, aptitude tests, or even background checks on social media. Just one caveat: when conducting skills tests, make sure the skills you test are actually required for the job.

Along with traditional screening methods, many recruiters will have state-of-the-art AI tools up their sleeve to help you streamline your search. Advanced software can help predict candidate outcomes, while chatbots can schedule interviews and engage candidates on your website.

It’s a two-way street

Don’t expect magical answers if you haven’t articulated the questions. As an employer working with a recruiter, you’ll have to spell out your requirements. As soon as you can, arrange a meeting with your recruiter, and leave no stone unturned as you lay out what you’re looking for. A basic checklist of qualities doesn’t mean you can’t be flexible – your recruitment plan should include backup strategies to deal with unexpected hiring needs.

Once you’ve outlined your basic requirements, put your micromanaging hat in a drawer and leave the nitty-gritty to the recruiter. That’s what you’re hiring them for, after all. If you’ve done the prep work of articulating your needs and agreeing on a plan, you can trust that the recruiter will leverage their own networks, pre-screening systems, and software solutions to bring you a pool of high-quality candidates.

If you’re looking to expand a particular department or role, do your homework on current top performers. Consider: do they share a similar background, skill set, or personality type? Even better, ask the high flyers themselves what part of their education or experience has served them best on the job. Share their answers with your recruiter, who can use the insights to hone in on your next workplace superstar.

The post-pandemic world also calls for a leaner approach to hiring. Do you need a pipeline of candidates ready to jump in as needed, or can your organization tolerate a waiting period? Talk to your recruiter about your level of risk tolerance and need for hiring efficiency.

Just in time or just in case?

The “just in case” model puts a priority on candidates who are already trained in every skill they may need. While difficult to find, such candidates help you build resiliency. The “just in time” model seeks employees who are trained in a specific skillset and nothing more – and in some cases, called in only when needed. Both models have their perks; it’s budget and company culture that will determine which one to use and when.

HAPPY RECRUITING

Done right, recruiting is not only productive and cost-effective, but enjoyable for everyone involved.

Our Sci.bio recruiters take pride in delivering results and building relationships. They come from a variety of backgrounds, and possess their own wide talent networks to draw from. From general to specific, entry-level to expert, our recruiters can help you fill any po honesty over hype, and will work hard to find a match that makes everyone happy – a win-win-win.

If you’re a recruiter looking to join a team of like minded professionals, searching for efficient and expert assistance filling a role, or you’re interested in more information about how we operate here at Sci.bio, feel free to reach out to us here. We can help you learn how best to leverage our platform and technology to increase your success as a recruiter. We also invite you to browse through our blog posts to get a deeper sense of what recruiting can offer