Trusted CMC Advisors

Sean Forestell, PhD
Senior Vice President

Sean Forestell, Ph.D. is an expert in biologics process development and manufacturing with over 30 years of experience in the biotech industry. Dr. Forestell has had senior leadership roles in several companies including BioMarin, Genentech and Novartis. At BioMarin, he was the Senior Director of MSAT responsible for technical process support of 5 commercial and 4 clinical products across 4 manufacturing facilities. He has developed processes and been involved in the successful tech transfer of 12 early-stage clinical products, 4 successful PPQs that led to licensure, and has supported the manufacture of 8 different commercial products.

His broad experience includes products that range from viral vectors used in cell and gene therapy, monoclonal antibodies, and enzymes to treat ultra rare diseases that are produced using continuous manufacturing technologies. Dr. Forestell was educated at the University of Guelph, earning a BSc in Biological Engineering and a Ph.D. in Chemical Engineering from the University of Calgary. He has co-authored 19 articles in peer-reviewed journals and is an inventor on two issued patents. | Learn More

Steven Chamow, Ph.D.
Principal Consultant

Steven Chamow is an experienced biotechnology executive and consultant, with more than 35 years of biopharmaceutical experience. As principal consultant, Dr. Chamow draws on his extensive technical and product development background to assist biotechnology companies in designing and developing CMC strategies for products in development, including transfer to and implementation by qualified CDMOs.

Prior to founding Chamow & Associates, Dr. Chamow served as senior vice president, CMC at Intradigm Corporation, a private biopharmaceutical company focused on developing RNAi therapeutics (acquired by Silence Therapeutics). Prior to Intradigm, Dr. Chamow was vice president, process sciences, at Genitope Corporation and at Abgenix, Inc. (acquired by Amgen), where he built the company’s process sciences department and co-led the design and construction of Abgenix’s award-winning mammalian-cell production facility in Fremont, CA. | Learn More

Peter Alexander, Ph.D.
Senior Consultant, CMC
Upstream Process Development/ DS Manufacturing

Peter Alexander, Ph.D., is a Senior Consultant for CMC at Alira Health. Peter has more than 35 years of experience in the biopharmaceutical industry. Peter supports clients by overseeing DS operations at CDMOs, including reviewing protocols, reports and manufacturing batch records. His specialties include microbial fermentation and mammalian cell culture process development and scale-up, purification process development, technology transfer, manufacturing sciences, cGMP manufacturing and biological and chemical safety programs. Peter holds a PhD in Microbiology from the University of Hawaii. | Learn More

Bill Perry, Ph.D.
Senior Consultant, CMC
Downstream Process Development/Conjugation/ DS Manufacturing

Bill Perry, Ph.D., is a Senior Consultant for CMC at Alira Health. Bill is a bioprocess engineering technical leader with 17 years of experience in industry. Bill supports clients by overseeing DS operations at CDMOs, including reviewing protocols, reports and manufacturing batch records. His experience includes products at various stages of development, from pre-clinical/clinical development and manufacturing, through process validation and commercialization. He has expertise in biologic products from mammalian cell culture and microbial fermentation. Moreover, he has skills in synthetic oligonucleotide and protein-payload conjugated products. He holds a PhD in Chemical Engineering from the Massachusetts Institute of Technology. | Learn More

Katie Black, Ph.D.
Consultant, CMC
Analytical Method Development and QC

Katie Black, Ph.D., is a Consultant for CMC at Alira Health. Katie Black is an experienced leader with 10 years industry experience and a multidisciplinary background spanning preclinical research through analytical development/CMC and clinical assay support. Katie’s support for clients includes overseeing the development, transfer, implementation and qualification of analytical methods at contract laboratories and CDMOs, including reviewing protocols, reports and SOPs and interpreting analytical data. Her tenure at BioMarin Pharmaceutical showcased her diverse skills in biomarker and product characterization assay development for protein therapeutics. Katie holds a BS in Chemical Engineering from Northeastern University, and a PhD in Bioengineering from UC Berkeley, with earlier industry experience at Albany International, Genzyme, and Draper Labs. | Learn More

Nick Gaspar, Ph.D.
Senior Consultant, CMC
Bioanalytical Method Development and QC

Nick Gaspar, Ph.D., is a Senior Consultant for CMC at Alira Health. With over 26 years of experience in leadership roles in six biotech companies, Nick has expertise in antibodies, peptides, growth factors and oncolytic viruses (OV’s) and a background that spans drug development phases from discovery research, through clinical validation, and manufacturing. Nick’s support for clients includes overseeing the development, transfer, implementation and qualification of bioanalytical methods (specifically potency methods) at contract laboratories and CDMOs, including reviewing protocols, reports, SOPs and trending and interpreting analytical data. He received a BS (Zoology) and PhD (Molecular Biology and Biochemistry) from UC Davis. He has published 7 papers and is a co-inventor on 2 patents.

Sanjeevani Ghone, Ph.D. MBA
CMC Operations Management Executive

Sanjeevani is a CMC Operations Management Executive, founder, and consultant of Sachemie Consultancy LLC, providing consultative support in CMC operations to biotech and pharmaceutical clients. In her most recent position, she was the Site Head and Senior Vice President of Chemistry Operations at Abzena, Bristol, PA. She has over 25 years of experience in discovering, developing, and manufacturing small and large molecules. Her expertise includes the development of complex small molecules (payloads, payload-linkers, polymers, peptides, carbohydrates, etc.), bioconjugates, and Antibody-drug conjugates. Sanjeevani led several cross-functional teams in operations to move advanced therapeutic molecules from discovery to IND. She co-authored several patents, publications, and review articles.

Sanjeevani served as Subject Matter Expert to biotechnology innovators and investors for open innovation and emerging business models. She achieved the strategic objectives through mergers and acquisitions to maintain industry leadership and was an advisor for due diligence, technology assessment, portfolio review, and post-acquisition integration.

Stephen Nava
Quality Assurance/Regulatory Affairs

Steve is a Quality Assurance/Regulatory Affairs Professional with 30+ years of experience in cGMP compliance and quality systems. Steve is an ISO9000-trained auditor with a solid foundation in worldwide quality and regulatory requirements and a thorough knowledge of cGMP guidelines. His experience includes auditing vendors for phase appropriate clinical development through mock-PAI readiness. Completed 100+ audits across the supply chain including intermediates/key starting materials, biologically active substance, drug substance, parenteral, solid oral dosage, topical and medical device manufacturing operations within the United States, Europe, China, Japan, Southeast Asia, and India. Experience includes both small and large molecules (i.e., monoclonal antibodies (mAb), Antibody-drug conjugates (ADC), Biosimilars, and Bispecific antibodies (bsAbs)). Developed/Managed quality assurance/regulatory affairs, compliance, and medical writing departments. Implemented phase-appropriate quality systems, managed supply chains, provided CMC regulatory submission strategy for both US and ex-US dossiers, authored modules 2 and 3 for INDs, IMPDs, NDAs and MAAs in eCTD format and provided oversight for project technology transfer of manufacturing/analytical operations.

Chris Garten
Quality Assurance, Quality Control, Supply Chain

Chris Garten is an executive Quality professional with over 30 years of global Quality Assurance, Quality Control, Supply Chain and organizational leadership in pharmaceutical, biologics, and cell & gene development. With an extensive background in GMP, GCP, GLP, and GVP, Chris has proven success in navigating complex regulatory environments, including 21 CFR 210/211/1271, 21 Part 11, GAMP5, GCP ICH Guidance, and corresponding EU Tissue and Cell Directives. Chriss's experience spans R&D translational, clinical, and commercial quality for small molecules, large molecules, and advanced therapies. Chris has 15 years of senior leadership at emerging companies such Synthekine, BlueSphere Bio and PACT Pharmaceutical developing and implementing phase appropriate quality strategies and systems supporting global Phase 1-3 cell and gene therapy clinical studies. Prior to his transition into emerging technologies, Chris supported organizations such as GlaxoSmithKline, Schering Plough Research Institute, Forest Laboratories, Inc., Aventis Pharmaceutical, and Johnson & Johnson with a focus on global quality operations. Throughout his career, Chris has been a key quality liaison for health authorities including FDA, EMA, MHRA, and Asian health authorities.

Nats Rajagopalan
Biologics Formulation Development and Drug Delivery

Nats Rajagopalan is an experienced biologics drug product development consultant with more than 40 years of experience in the pharmaceutical industry in both technical and management roles. Over his career in the industry, Dr. Rajagopalan has been involved in the development of biotechnology drug products, drug delivery systems and gene therapy systems for the delivery of nucleic acids. He has a broad background and expertise in the preformulation and formulation development of biologics including peptides, fusion proteins and monoclonal antibodies, development of combination drug products in prefilled syringe systems and in technology transfer and commercial manufacturing of solution and lyophilized drug products.

Dr. Rajagopalan has worked extensively in the area of high concentration biologics for delivery of biotherapeutics by the subcutaneous route. He has been involved in the clinical and commercial development of high concentration formulation of monoclonal antibodies and has a strong understanding of PK/ADME aspects related to subcutaneous delivery. He has broad experience in conducting due diligence evaluations for assessment of new technologies and for in licensing of early and late phase assets.

Lars Schuller

Lars brings over 20 years of Manufacturing and Quality Assurance experience in Pharma, Biotech and Medical Devices. He has extensive experience in the establishment and remediation of Quality Systems, Change Control (process, material, and facility) as well as process design and continuous improvement. He brings a practical approach to managing and solving issues based on experience and industry best practices. Lars holds a BS in Biochemistry with a second major in Chinese from Trinity University in San Antonio and an MBA from University of California, Los Angeles.

Melisa Carpio

Melisa Carpio has over 20 years of experience in the biotechnology industry working at Genitope, MedImmune, Takeda, Sartorius, and Repligen. The core of her expertise is in cell line development and upstream bioprocessing. She has a proven track record of supporting the advancement of molecules from discovery to the clinic and has worked with over 100 clients using various cell lines (CHO, 293, insect, yeast, bacteria), molecule types (mAb, ADC, cell and gene therapy), expression systems, and bioreactor platforms.

As a Senior Consultant, Melisa’s project involvement includes global CDMO sourcing and oversight, technical support for program advancement, due diligence, technical writing for regulatory submissions, technology benchmarking, and market assessments.

Melisa has a B.S. and M.S. in Chemical Engineering from the University of California, Berkeley and Management of Technology Certification from the Haas School of Business.

Peter Hocknell, PhD
CMC Analytical Development and Quality Control

Peter Hocknell has over 22 years of experience in the field of analytical development for a wide range of biologic modalities. These include enzyme replacement therapies, therapeutics viruses, monoclonal antibodies, and fusion proteins with multiple specificities. As senior consultant, Dr Hocknell uses his experience solving assay development challenges to assist biotechnology and biopharma companies in designing and validating analytical strategies for products in their development pipeline. This often includes method transfer to, and qualification / validation by, qualified CROs.

Originally trained as a viral immunologist, Dr Hocknell gained an appreciation for the importance of high-quality and robust analytical assays to help answer perplexing scientific questions early in his career. These include cell-based potency assays, which can be particularly challenging to develop but offer critical insights into a therapeutic agent’s mechanism of action in the patient. In addition, Dr Hocknell has extensive experience preparing INDs/IMPDs for Regulatory submissions to Health Authorities in the US, Europe, and Asia.

Greg Davies
Formulation Development, Manufacturing, New Product Introduction

Greg Davies is an expert in formulation development, manufacturing, and new product introduction with over 30 years industry experience. He has held senior positions at SmithKline Beecham, GSK, and Impel Pharmaceuticals, a small Seattle based biotech. These have included positions in manufacturing technical support, new product development, new product introduction and supply chain, contributing to over fifty new products. His areas of expertise include formulation development, product remediation, process development and technology transfer, manufacturing sourcing evaluation and selection, and establishing commercial manufacturing and supply chain for new products.

Greg has managed large and small global teams in product development, technical support, and vendor management of CDMOs developing and manufacturing pharmaceutical products. Over his career, he has led development of conventional solid, liquid, and semi-solid dosage forms, as well as novel formulations and medical devices to improve drug delivery. He has also managed a global team responsible for the selection of the commercial site of manufacture, through technology transfer and establishing the supply chain for new product multi-market launches. Greg holds a B.Sc. in Chemistry from Hull University, UK.